A Randomised Control Trial Comparing Functional Outcomes for Navigated Kinematically Aligned TKR Versus Navigated Mechanically Aligned TKR

NCT04246138 | Recruiting

• 1 other identifier: IRAS project no is 234077
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to compare navigated kinematically aligned total knee replacements (KA TKR) with navigated mechanically aligned TKR (MA TKR) in terms of function and ROM The objectives are therefore:

1. 1.To compare the functional outcomes of KA TKR versus MA TKR performed using navigation technique
2. 2.To compare ROM and alignment of knee in the two groups

Conditions

Kinematical Alignment,Mechanical Alignment, Navigation

Outcome Measures

Primary Outcomes (1)

• KOOS

  knee osteoarthritis outcome score preop and at 12 months

  12 months

Secondary Outcomes (8)

• • Knee ROM and stability (pre-op and at 1 year postop)

  1 year

• • Oxford knee society score

  1 year

• • SF-12

  1 year

• • EQ5D

  1 year

• • Time taken for operation (tourniquest time)

  1 year

Study Arms (2)

kinematically alignment

ACTIVE COMPARATOR

Procedure: alignment types

mechanical alignment

ACTIVE COMPARATOR

Procedure: alignment types

Interventions

alignment types PROCEDURE

types of alignment mechanical versus kinematic of TKA to be studied

kinematically alignment; mechanical alignment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 90 years
• Diagnosis of degenerative osteoarthritis

You may not qualify if:

• o a)Post traumatic arthritis
• b)Varus /valgus deformity of more than 20 degrees
• flexion contracture of more than 20 degrees
• reduced ability to make decision like dementia patients/children
• e)if they had undergone any orthopaedic procedure to the lower limbs within the last one year
• h) neuromuscular or neurosensory deficiency
• I)inflammatory arthritis of the knee joint
• patients who suffered a complication which might influence the final outcome such as a deep infection, fracture or dysfunction of the extensor mechanism in post-operative period. However the complication rate data will be analysed and reported.
• pregnancy
• patients involved in other clinical trials within last 6 months prior to being recruited in the study

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University teaching hospitals

Hull, East Yorkshire, HU3 2JZ, United Kingdom

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: randomisation done by software
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: February 18, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)